SUPPLY CHAIN ARTICLES
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"Mirror, Mirror…": Reflections On Reducing mRNA Production COGS
Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions
Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
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Plasmid Production: 3 Key Takeaways For mRNA Manufacturing
Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
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4 Risk Mitigation Strategies For mRNA Production
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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Inside Alnylam's Playbook For High Volume siRNA Production
As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
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Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.